Senior Program Manager

2 months ago

Sacramento, California, United States Inspire Medical Systems, Inc. Full time


ABOUT INSPIRE MEDICAL SYSTEMS

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus on patient outcomes is at the core of everything we do, and our "think I can" attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

WHY JOIN OUR FAST-GROWING TEAM

At Inspire, we value people - your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team

ABOUT THIS POSITION

This position involves leading program management of Inspire's next generation of products. This involves cross functional communication with quality, regulatory, clinical, operations, marketing, and sales, as well as leading product development teams of internal and external resources.

MAIN DUTIES/RESPONSIBILITIES:

  • Lead cross-functional technical teams to develop and commercialize new products that support business initiatives
  • Lead communication with cross functional stakeholders to review project status and resource needs
  • Support product launches in partnership with Quality, Regulatory, Operations, Marketing, Sales & Clinical Training
  • Oversee internal and external design and test resources including work with contract manufacturers
  • Develop and manage policies, process and procedures that affect program management
  • Ensure all quality system, regulatory, legal, and business requirements are met in the course of product development and market delivery
  • Assure compliance with industry applicable standards for medical devices
  • Generate and approve design history file documents, device master record documents and engineering change order records
  • Support post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations.
  • Attend patient cases and support Inspire customers as assigned

Required Qualifications:

  • Bachelor's degree in engineering or related field.
  • Experience managing the process of designing, developing, and delivering innovative medical technology.
  • Experience interfacing and communicating with cross functional stakeholders
  • Experience establishing and building highly effective product development teams consisting of internal resources, contract resources, and large external vendors.
  • Experience managing timelines, budgets, and identifying critical path constraints
  • Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing
  • Demonstrated Ability to Solve Problems

Preferred Qualifications:

  • Master of Business Administration (MBA) or a Master's degree in engineering or related field
  • Experience leading multiple active implantable medical product development programs
  • Experience leading cross functional communication and resource planning
  • Extensive experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.
  • PMP Certification
  • Experience Building Plan Models using Monte Carlo Simulation
  • Experience with Smartsheets or other Portfolio and Program Management (PPM) Platforms to plan programs, build dashboards and use as a program communication tool

Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Inspire Medical Systems is anequal opportunityemployer with recruitment efforts focused on ensuring a diverse workforce.Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at or email (dot)com

Inspire Medical Systems participates in E-Verify.



Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status with regard to public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at or email

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